An Observational Study of Patients' Perception of Treatment With Erythropoiesis-Stimulating Agents in Patients With Chronic Kidney Disease Not on Dialysis (PERCEPOLIS)

Anemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042833
• Other study ID #: ML25557
• Status: Completed
• Phase: N/A
• First received: January 21, 2014
• Last updated: November 2, 2015
• Start date: May 2011
• Est. completion date: June 2012

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés (CNIL)
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate patients' perception of treatment with erythropoiesis-stimulating agents in patients with chronic kidney disease not on dialysis. Eligible patients initiated on treatment with Mircera (methoxy polyethylene glycol-epoetin beta) will be followed for 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Patients with chronic kidney disease not on dialysis (with or without previous renal transplantation)

• Treated or not with ESA at time of visit

• Patients for whom the treating physician had decided to initiate Mircera for medical reasons before the commencement of the study

• Initiation of treatment with Mircera at the inclusion visit

• Accepting and able of completing the ESA preference questionnaire

Exclusion Criteria:

• Participation in a clinical trial on anemia

• Treatment with Mircera during the 3 months before inclusion

• Dialysis planned in the next 6 months

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative importance for patients of different attributes of ESA treatment, assessed by Choice Based Conjoint questionnaire at baseline and Month 6		6 months	No
Secondary	Biological parameters: hemoglobin concentration at each observation time point.		6 months	No
Secondary	Adherence to Mircera treatment assessed by a questionnaire adapted from the Morisky scale at baseline and at Month 6		6 months	No
Secondary	Dose/schedule of Mircera treatment at each observation timepoint		6 months	No
Secondary	Concomitant medication/treatments in the management of anemia		6 months	No
Secondary	Proportion of patients with a hemoglobin level between 10 and 12 g/dL after 6 months of treatment with Mircera		Month 6	No
Secondary	Change in hemoglobin level		from baseline to Month 6	No
Secondary	Safety: Incidence of adverse events		6 months	No